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January 15, 2021 05:00am
By Aislinn Antrim, Associate Editor
Officials with the FDA have given approval for marketing Brainswayâ€™s Deep Transcranial Magnetic Stimulation System for treatment of obsessive compulsive disorder.
Officials with the FDA have given approval for marketing Brainsway’s Deep Transcranial Magnetic Stimulation (TMS) System for treatment of obsessive compulsive disorder (OCD).
“Transcranial magnetic stimulation has shown its potential to help patients suffering from depression and headaches,” said Carlos Peña, PhD, MS, director of the Division of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health, in a prepared statement. “With today’s marketing authorization, patients with OCD who have not responded to traditional treatments now have another option.”
TMS is a procedure that utilizes magnetic fields to stimulate nerve cells in the brain. The FDA permitted marketing of TMS as a treatment for major depression in 2008, and the agency expanded the use to include TMS for treating pain associated with certain migraine headaches in 2013.
The FDA reviewed the Brainsway device through the de novo premarket review pathway, a regulatory pathway for some low- to moderate-risk devices that are novel and for which there is no legally marketed predicate device to which the device can claim substantial equivalence.
Prior to permitting Brainsway to market its device, the FDA reviewed data from a randomized, multicenter study of 100 patients. Forty-nine of these patients received treatment with the Brainsway device, and 51 patients received treatment with a nonworking device. Patients already receiving OCD treatments were maintained at their current dosages throughout the study.
The study evaluated the reduction in patients’ Yale-Brown Obsessive Compulsive Scale (YBOCS) score, a common metric for measuring the severity of a patient’s OCD. The results indicated that 38% of studied patients responded to the Brainsway device (i.e., greater than 30 percent reduction in YBOCS score), whereas 11% of patients responded when using the sham device.
The most frequent adverse reaction was headache, reported by 37.5% of the patients who received the Brainsway device, and by 35.3% of the patients who received the sham treatment. No serious adverse reactions related to the Brainsway device were reported. Other adverse reactions, such as application site pain or discomfort, jaw pain, facial pain, muscle pain, spasm or twitching, and neck pain, were reported as either mild or moderate, and were resolved shortly after treatment.
The Brainsway device is contraindicated for patients with metallic objects or implanted stimulator devices in or near the head, including cochlear implants, deep brain stimulators, vagus nerve stimulators, other implanted electrodes or stimulators, aneurysm clips or coils, stents, bullet fragments, jewelry, and hair accessories. During treatment with the device, the patient must use earplugs to reduce exposure to the loud sounds produced by the device. Patients with a history of seizures should discuss their history with their health care provider before receiving the device.
FDA permits marketing of transcranial magnetic stimulation for treatment of obsessive compulsive disorder [news release]. Silver Spring, MD; August 17, 2018: FDA website.https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm617244.htm. Accessed August 20, 2018.